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    规范、指南、共识
  • 规范、指南、共识
    HAN Lizhu,YIN Qinan,BIAN Yuan,HUANG Xuefei,LEI Yang,TANG Lingxi,TONG Rongsheng
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    In June 2021,the European Society of Cardiology released Patient profiling in heart failure for tailoring medical therapy. A consensus document of the Heart Failure Association of the European Society of Cardiology.The consensus points out that despite guideline recommendations and available evidence,implementation of treatment for heart failure (HF) is poor.The majority of patients have not prescribed drugs at target doses,which is mainly related to low blood pressure,slow heart rate,impaired renal function, or hyperkalaemia.The consensus identified nine profiles that may be relevant for treatment implementation in HF patients with a reduced ejection fraction,adjusted guideline-directed medical therapy to patient profiles,may allow to achieve a better and more comprehensive therapy for each patient than the traditional forced titration therapy.Compared with the heart failure guidelines update: defining a new pharmacological standard of care for heart failure with reduced ejection fraction jointly issued by the Canadian Cardiovascular Society and the Canadian Heart Failure Society in April 2021,this consensus focuses on personalized treatment suggestions according to the different patient profile.This paper interprets the consensus to provide a reference for the medical therapy of HF patients in China.

  • 药物研究
  • 药物研究
    ZHANG Ping,YU Ying,HU Feng,CHEN Hongxiang
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    Objective To analyze the proportion of cytotoxic T-17 (Tc17) cells in imiquimod-induced psoriasiform dermatitis in mice and the expression of related cytokines. Methods BALB/c male mice were randomly divided into two groups: the psoriasiform dermatitis model group induced by topically applying 5% imiquimod (IQM) ointment and the normal control group.The percentage of Tc17 and helper T-17 (Th17) cells were detected and sorted by flow cytometry in the blood of the two groups,and the expression levels of IL-17A,IL-22,RORγt,and STAT3 in Tc17 cells were detected by real-time quantitative PCR (RT-qPCR). Results The percentage of Tc17 and Th17 cells in the model group was (4.63±0.10)% and (8.30±1.67)%,respectively.Moreover, those in the normal control group were (0.30±0.07)% and (1.47±0.40)%,which were significantly higher in the model group than in the normal control group (P<0.01).The expression levels of IL-17A,IL-22,RORγt and STAT3 in Tc17 cells in model group after flow sorting were (3.13±0.49),(2.41±0.22),(3.35±0.22),(2.02±0.40),significantly higher (P<0.01) than those in the normal control group [(0.95±0.21),(1.11±0.10),(1.09±0.27),(0.89±0.17)],respectively. Conclusion Tc17 cells are involved in the pathogenesis of psoriasiform dermatitis,and their differentiation and action mechanism are similar to those of Th17.The mice models induced by IMQ can mimic the changes of immune-related cytokines.

  • 药物研究
    LI Dengke,SONG Lingyu,HE Xidong,HU Yue,YANG Hong,LIU Qi
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    Objective To clarify the effect of celastrol (cel) on methionine-choline-deficiency (MCD) induced non-alcoholic steatohepatitis (NASH) in mice. Methods The mice were randomly divided into the MCS group,MCD group and MCD+cel group,with six mice in each group. The MCS group was given a methionine-choline-sufficient(MCS) diet.MCD group was given MCD diet.The MCD+cel group was given MCD diet and intraperitoneal injection of celastrol (1 mg·kg-1,once every other day).Feeding lasted for five weeks,and the mice's body mass and liver mass were weighed and recorded.The degree of hepatic steatosis in mice was observed by H&E staining.Liver disease activity was evaluated by non-alcoholic fatty liver disease activity score (NAS).Lipid deposition was observed by oil red method staining.Biochemical reagents were used to detect TG,ALT and AST levels.The expressions of F4/80 and IL-1β were detected by qPCR. Masson's staining observed the degree of liver fibrosis.The positive cells of COL1A1 were observed by immunohistochemistry. Results Compared with the MCS group,body mass and liver mass of mice in MCD group were significantly reduced (P<0.01).In MCD group,liver steatosis and NAS were significantly increased (P<0.01).There was obvious lipid deposition in liver and TG content was significantly increased (P<0.01).ALT and AST in the serum of mice increased significantly (P<0.01).F4/80 and IL-1β were significantly increased (P<0.01).There was more fibrous hyperplasia in liver,and the positive COL1A1 cells increased significantly(P<0.01). Compared with MCD group,liver steatosis in MCD+cel group was significantly reduced,and NAS was significantly decreased (P<0.01).Liver lipid deposition was significantly reduced,and TG content was significantly decreased (P<0.05).ALT and AST levels were significantly decreased (P<0.05).The levels of F4/80 and IL-1β were significantly decreased (P<0.05).Fibroplasia in the liver decreased and the positive COL1A1 cells decreased (P<0.01). Conclusion Celastrol can inhibit NASH induced by MCD diet in mice.

  • 药物研究
    ZHU Yanyan,FENG Yanlin,MEI Ziwei,HU Guoxin,PING Li,TIAN Weiqiang
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    Objective To study the pharmacokinetics effect of total saponin of ginseng (Panax ginseng C.A.Meyer) on irinotecan and its derivative in rats. Methods SD rats were randomly divided into an experimental group and a control group.Total saponin of ginseng (400 mg·kg-1) was given to the experimental group once, and then irinotecan 20 mg kg-1 was injected into the tail vein half an hour later.Normal saline and irinotecan were given to the control group in parallel.The blood was taken at different time points after administration.The plasma concentrations of irinotecan and its active metabolite SN-38 were determined by the ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method,and the pharmacokinetic parameters were calculated by DAS 3.1 software.The results were analyzed by SPSS 21.0 statistical software. Results The main pharmacokinetic parameters of irinotecan in the experimental group were as followed: t1/2=(5.527±1.156) h,AUC0-t=(2.078±0.118) μg·h·L-1, MRT0-t=(0.462±0.023) h, and MRT0-∞=(1.405±0.212) h.The main pharmacokinetics parameters of irinotecan in control group were as followed: t1/2 =(0.296±0.011) h,AUC0-t=(2.161±0.146) μg·h·L-1,MRT0-t=(0.360±0.026) h,and MRT0-∞ =(0.391±0.026) h.The main pharmacokinetic parameters of SN-38 in experimental group were as followed: t1/2=(1.398±0.045) h, AUC0-t=(9.073±0.109) μg·h·L-1,MRT0-t=(2.337±0.081) h,and MRT0-∞=(2.408±0.089) h.And those of SN-38 in control group were as followed:t1/2=(0.928±0.050) h,AUC0-t=(8.933±0.434) μg·h·L-1,MRT0-t=(1.869±0.061) h,and MRT0-∞ =(1.935±0.066)h.Compared with the control group,the t1/2 of SN-38 in the experimental group were significantly prolonged (P<0.05). Conclusion When the total saponin of ginseng is combined with irinotecan,the t1/2 of SN-38 can significantly increased in rats.

  • 上市药品安全性评价专栏
  • 上市药品安全性评价专栏
    YANG Jing,YANG Yao,WU Bin,XU Ting
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    Objective To excavate and analyze signals of antibody-drug conjugate (ADC) related adverse events of peripheral neuropathy through data mining methods based on the big data of FAERS,and to provide a reference for the safe clinical use of ADC drugs. Methods A total of 40 quarters of FAERS data from the first quarter of 2011 to the fourth quarter of 2020 were downloaded.After data cleaning, such as weight removal and adverse event system classification,ADC-related peripheral neuropathy adverse events was extracted and signal detection were performed using Reporting Odds Ratio method (ROR) and Information Component method (IC). Results A total of 15 245 adverse events was reported with eight ADC drugs as primary suspected drugs,and 912 peripheral neuropathy events were gathered,among which four ADC drugs and peripheral neuropathy events were detected as signals: Brentuximab vedotin(BV) ROR=14.56,95%CI(13.35,15.87);IC=3.71,95%CI(3.39,3.96);ado-trastuzumab emtansine (TDM-1) ROR=7.59,95%CI(6.69,8.62);IC=2.85,95%CI(2.40,3.23);polatuzumab vedotin (PV) ROR=11.63,95%CI(8.99,15.06);IC=3.42,95%CI(2.37,4.07);enfortumab vedotin (EV) ROR=7.83,95%CI(4.72,12.97);IC=2.89,95%CI(0.80,4.05).ADC-related peripheral neuropathy events that cause death outcomes were obtained,including 86(15.81%) of BV,11(5.21%) of TDM-1,and 6(9.68%) of PV.Analysis of event time showed that the incidence of events on the first day of medication was as follows: BV 47(21.76%),TDM-1 2(6.67%),PV 5(26.32%),EV 1(20.00%). Conclusion It is suggested that more attention should be paid to the risk of ADC-related peripheral neuropathy events,and the monitoring of clinical medication use should be strengthened to reduce the impact of adverse reactions on patients' prognosis and quality of life.

  • 上市药品安全性评价专栏
    TANG Furong,HUANG Xing,CHEN Li,WANG Danqing
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    Objective To explore and analyze the adverse events(ADEs) signals of levonorgestrel intrauterine system (LNG-IUS). Furthermore, to provide a reference for its clinical safety. Methods The reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method were adopted to conduct data- mining adverse events in the US Food and Drug Administration Adverse Event Reporting System (FAERS),from the first quarter of 2016 to the first quarter of 2021. Results A total of 39 306 ADEs reported cases with the levonorgestrel intrauterine system as the first suspected drug were found,and 438 ADEs signals were detected,involving 24 system organ classifications.Fourteen of the 81 ADEs signals were not mentioned in the labels after the second screening,which involved eight system organ classifications and happened to patients mainly between the ages of 18 to 50. Conclusion New ADEs signals may be related to LNG-IUS,and clinical monitoring of LNG-IUS should be strengthened.

  • 上市药品安全性评价专栏
    HE Xucheng,LIU Yanxin,WU Pan,SHU Yamin,WANG Shuangmei,CHEN Li
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    Objective To explore the difference in data mining of adverse drug event(ADE) signals for olaparib in different mining periods based on the FDA adverse events reporting system (FAERS) database and provide a certain reference for reasonable adverse signal mining. Methods Using reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods to mine ADE signals of olaparib,which are grouped in different mining periods,from the first quarter of 2015 to the second quarter of 2021 in the FAERS database. Results The number of olaparib adverse events is increasing yearly, with the most significant number of reports coming from North America, and far more women than men reported it.The reason might be that FAERS database are located in the United States American. After signal mining of olaparib adverse events, we found that the number of ADE increases with the increase of mining time.But the increase rate is gradually decreasing.The change also follows the above rules when data mining is in reverse order. Conclusion With the prolonged time to market for olaparib, the number of ADE will enter a stable stage,It can better warn the relationship between olaparib with ADE and obtain a more comprehensive signal since the listing by using the real-world data in recent years.Therefore,it is recommended to mine the recent data after the drug has been on the market for a time to have enough reports when digging for ADE.

  • 上市药品安全性评价专栏
    LIU Yanxin,ZOU Jian,DONG Changjiang,SHU Yamin,HE Xucheng,WU Pan,CHEN Li
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    Objective To provide a reference for the clinical use of four glucagon-like peptide-1 receptor agonists(GLP-1RAs) based on the U.S.Food Drug Administration adverse event reporting system (FAERS),and to explore the characteristics of ADE occurrence and the correlation between ADE and drugs. Methods We use reporting odds ratio (ROR) method and the medicines and healthcare products regulatory agency (MHRA) method to mine the adverse reaction signals of four GLP-1RAs based on the adverse reaction report data from the first quarter of 2017 to the fourth quarter of 2020 extracted from the FAERS database.After valid signals were obtained,the ICH medical dictionary for drug regulatory activities (MedDRA) was used for translation and system organ classification. Results A total of 487 signals were detected for the four GLP-1RAs,including 203 signals from exenatide,123 signals from dulaglutide,116 signals from liraglutide and 45 signals from lixisenatide,which involved 26 different system organ classes (SOCs).Exenatide mainly focused on general disorders and administration site conditions (the number of adverse events,n=17 757),and general disorders and administration site conditions (n=10 073).Dulaglutide mainly focused on gastrointestinal disorders(n=12 302),and general disorders and administration site conditions(n=11 232).Liraglutide mainly focused on gastrointestinal disorders (n=4380),and investigations(n=892).Lixisenatide mainly focused on investigations(n=382),and injury,poisoning and procedural complications (n=223). Conclusion The common ADE signals and ADE-involved systems obtained in this study are consistent with the instructions,confirming the reliability of the research method. However, the major systems involved in ADE involving four GLP-1RAs are different,which can provide a reference for clinical drug use and promote rational drug use.

  • 上市药品安全性评价专栏
    WANG Zhaojian,YAN Yilong,GUO Shanshan,ZHAO Zhigang,HUO Jiping,LI Cao
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    Objective To investigate the utilization and rationality of perphenazine in many hospitals in China by real-world study methods. Methods A total of 5556 prescriptions of perphenazine for outpatients in 42 hospitals from 2017 to 2019 were selected to analyze whether the utilization of perphenazine corresponded to the indications based on the instructions.We collected supporting pieces of evidences from various databases to analyze the rationality and influencing factors of off-label utilization of perphenazine by binary logistic regression. Results The rate of off-label utilization was 43.3%.The most frequent off-label diagnosis was the mental disorder.The prevalence of off-label medication in patients aged 12-17 (50.0%) and over 65 (56.3%) was higher than that in patients aged 18-65 (37.0%).The prevalence of off-label medication in non-psychiatric departments (82.8%) was higher than that in the psychiatric department (33.8%).The prevalence of off-label prescriptions in non-first tier cities (72.1%) was higher than that in first-tier cities (39.7%).Regression analysis showed that region, time, department, insurance and insurance category, age, number of diagnoses, number of combined drugs and gender would affect the occurrence of off-label prescriptions.When perphenazine was used alone, the prevalence of off-label medication was the highest among all the prescriptions, which was 63.3%.The most common poly-pharmacy was an antipsychotic with another antipsychotic. Conclusion The perphenazine is often off-label prescribed, which must be standardized managed.In addition, the off-label prescription must be monitored and studied to provide more pieces of evidence for the rational use of perphenazine.

  • 上市药品安全性评价专栏
    WANG Jialin,ZHOU Li,WANG Zhong,XING Jia,GAO Xiang,YAN Shi,HOU Zhen,LIU Xiaobei,CAO Limin,LU Wenhui,SHAN Lihua,LYU Ying,CHANG Hesheng,Guo Rongjuan
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    Objective To observe the incidence,nature,and clinical manifestations of adverse drug events (ADE) and adverse drug reactions (ADR) of Wuling capsule to provide a basis for clinical safe drug use. Methods A multicenter prospective,single-arm clinical trial of centralized monitoring in the hospital was used to monitor the patients who used the Wuling capsule in 12 clinical research centers from June 15,2013 to December 31,2015.All ADR/ADE and their treatment to them,were recorded and analyzed. Results A total of 3004 patients were included,19 of them had ADE(0.63%),15 had ADR (0.50%).ADR is mainly concentrated in the digestive and nervous system,including anorexia,dry mouth,nausea,diarrhea,stomach discomfort,palpitation,dizziness,headache and other symptoms.But no related influencing factors were found. Conclusion The incidence of ADR in Wuling capsules is uncommon,and its clinical application is safe.

  • 药学进展
  • 药学进展
    LIN Chen,HOU Huan,PENG Cheng,YAN Shanle,CHEN Rong
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    Rheumatic diseases generally refer to a group of diseases that can affect bones,bone joints,muscles,and tissues, involving multiple organs and multiple systems.With the expansion of the clinical application of the existing disease-modifying anti-rheumatic drugs,their adverse reactions such as infection and the increase in cancer incidence of have gradually been exposed.And some patients have no response to the existing treatment drugs or cannot continue to respond.In recent years,biological disease-modifying anti-rheumatic drugs (bDMARDs) and targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs) had brought new hope for treating of rheumatism.This article reviewed the research progress of bDMARDs and tsDMARDs for the treating rheumatism in recent years,and provided a reference and basis for the treating rheumatism with drugs.

  • 药学进展
    HE Liling,YAN Xinming
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    Sepsis was defined as organ dysfunction caused by a dysregulated host response to infection,which has become one of the leading causes of death of clinical critically ill patients. However, the current treatment is only limited to active treatment of primary disease and symptomatic treatment. There is still a lack of effective means to contain the process. A growing body of evidence suggests that vitamin C, a physiological reductant, influences sepsis and the subsequent pathological process of septic shock and multiple organ dysfunction through multiple pathways. A variety of animal experiments and clinical studies on sepsis models have shown that timely and adequate vitamin C supplementation has a significant effect on the progression of the disease.

  • 药物制剂与药品质量控制
  • 药物制剂与药品质量控制
    TAO Li,WANG Yuting
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    Objective To establish a high-performance liquid chromatography(HPLC) method for simultaneous determination of calycosin-7-glucoside,ononin,9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside,calycosin,rhodiosin,rhodionin,rhodiolin,coniferyl ferulate,ligustilide and levistilide A in Jingtian quban capsules,and combine chemometrics to comprehensive evaluate the quality of Jingtian quban capsules. Methods The separation was performed by HPLC equipped with an Agilent ZORBAX SB-C18 chromatographic column. The mobile phase consisted of acetonitrile-0.2% formic acid in a gradient elution method.The column temperature was set at 30 ℃,and the flow rate was 0.9 mL·min-1.The detection wavelength were set at 254 nm for calycosin-7-glucoside,ononin,9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside and calycosin, 382 nm for rhodiosin, rhodionin and rhodiolin,and 280 nm for coniferyl ferulate,ligustilide and levistilide A.The cluster analysis and principal component analysis were conducted for the content results of ten constituents in Jingtian quban capsules by SPSS 26.0 statistical software. Results A good linear relationship was observed within the range of 4.18-167.20 μg·mL-1 for calycosin-7-O-β-D-glucoside,2.49-99.60 μg·mL-1 for ononin,3.07-122.80 μg·mL-1 for 9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside,1.81-72.40 μg·mL-1 for calycosin,5.69-227.60 μg·mL-1 for rhodiosin,3.46-138.40 μg·mL-1 for rhodionin,0.58-23.20 μg·mL-1 for rhodiolin, 8.77-350.80 μg·mL-1 for coniferyl ferulate,6.59-263.60 μg·mL-1 for ligustilide and 0.86-34.40 μg·mL-1 for levistilide A. The average recovery rates of each detected component of Jingtian quban capsules were 98.44%,97.87%,99.20%,96.95%,99.54%,100.09%,96.99%,99.72%,100.03% and 97.74% with the RSDs of 1.30%,1.51%,1.05%,0.98%,0.87%,0.72%,1.26%,0.86%,0.67% and 1.18%,respectively. The samples of 10 batches of Jingtian quban capsules could be divided in to 3 categories. The principal components 1-4 were the main factors affecting Jingtian quban capsules quality evaluation. Conclusion The method is accurate and reliable,and can be used to evaluate the quality of Jingtian quban capsules.

  • 药物制剂与药品质量控制
    ZHANG Yi,WANG Zhong,YANG Guisheng
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    Objective To establish a quality control method of Le'erkang syrup based on HPLC multi-index components and chemometrics analysis. Methods The analysis was performed on an Agilent TC-C18 column(250 mm×4.6 mm,5 μm);and the column temperature was 25 ℃.The mobile phase was the acetonitrile-0.1% phosphoric acid aqueous solution at a flow rate of 0.8 mL·min-1 in a gradient elution manner. The detector wavelength was set at 203 nm for heterophyllin B,305 nm for mulberroside A,moracin M and dihydromorin,and 254 nm for calycosin 7-O-β-D-glucopyranoside,ononin,formononetin and morusin. The chemometrics methods such as cluster analysis and principal component analysis were used to evaluate the quality of Le'erkang syrup from different manufacturers based on the results of multi-index components content determination. Results Heterophyllin B,mulberroside A,moracin M,dihydromorin,calycosin 7-O-β-D-glucopyranoside,ononin,formononetin and morusin showed good linear relationships within the ranges of 0.86-17.20,2.19-43.80,1.87-37.40,0.76-15.20,2.64-52.80,1.71-34.20,4.97-99.40,1.18-23.60 μg·mL-1 (r≥0.999 1),whose average recoveries were 98.51%,99.38%,97.72%,96.96%,98.70%,97.91%,100.08% and 99.03% with the RSDs of 1.15%,0.92%,1.36%,1.25%,1.47%,1.12%,0.76% and 0.83%,respectively. The cluster analysis results showed that 10 batches of Le'erkang syrup were clustered into two groups,and the results of principal component analysis showed that the principal component 1-2 was the main factor affecting the quality evaluation of Le'erkang syrup. Conclusion The method is easy to operate and repeatable,which can be valued as a quality control method for Le'erkang syrup.

  • 用药指南
  • 用药指南
    XU Rong,HUANG Chen,JI Jinru,YING Chaoqun,WANG Peipei,LIU Zhiying,XIAO Yonghong
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    Objective To evaluate optimal dosage for tigecycline against gram-negative organisms by Monte Carlo simulation. Methods The tigecycline's minimum inhibitory concentration (MIC) against 9674 gram-negative isolates collected from blood bacterial resistant investigation collaborative system (BRICS) were tested by broth dilution.Monte Carlo simulations were conducted to calculated probability of target attainment(PTA) and total cumulative fraction of response (CFR) of four different tigecycline dosage regimens. Results Tigecycline-susceptible strains accounted for 99.7% and 85.8% in Enterobacterales and Acinetobacter baumannii,respectively.All the simulated tigecycline regimens reached >90% PTA against isolates with MICs≤0.5 mg·L-1.Against isolates with MICs 1-2 mg·L-1,increasing daily dosage was needed to achieve higher PTA at relatively high MICs.The simulated regimen of tigecycline 100 mg loading dose followed by 50 mg q12h showed a promising CFR(>90%) against Enterobacterales.For Acinetobacter baumannii,a disappointing CFR(<50%) was achieved even for the highest daily dosage of tigecycline 200 mg loading dose followed by 100 mg q12h. Conclusion Tigecycline could be empirically used in treating bloodstream infections caused by Enterobacterales,but not suitable for that of Acinetobacter baumannii.

  • 用药指南
    ZHOU Yizheng,HUANG Chen,JI Jinru,YING Chaoqun,WANG Peipei,LIU Zhiying,XIAO Yonghong
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    Objective To optimize the dosage regimes of vancomycin and teicoplanin in treating methicillin-resistant st aphylococcal bloodstream infection based on Monte Carlo simulation. Methods One thousand two hundred and thirty-five strains of Staphylococci were collected from fifty-six Chinese hospitals which belong to BRICs.All strains were identified by microbial mass spectrometry. The cefoxitin discs detected Methicillin-resistant Staphylococci.The broth dilution method determined the minimal inhibitory concentrations of vancomycin and teicoplanin.The specific operation and judgment criteria followed the Clinical and Laboratory Standards Institute documents. In the pharmacokinetics of vancomycin and teicoplanin in adults with different renal functions.The CFR and PTA were simulated by Crystal Ball software. Results None of the four vancomycin dosing regimens achieved CFR for the flora in normal renal function.The CFR of 1000 mg, q12h and 1000 mg, q8h may reach 90% in moderate or severe renal insufficiency.Under all three renal functions,all four teicoplanin dosing regimens had CRF values less than 90% for Staphylococcus aureus and Staphylococcus haemolyticus;some dosing regimens may have CRF values greater than 90% for Staphylococcus hominis,Staphylococcus epidermidis,and Staphylococcus capitis. Conclusion When empiric treatment of bacteremia caused by methicillin-resistant Staphylococcus,vancomycin 1000 mg q8h and teicoplanin 600 mg q12h are the most likely dosing regimens to achieve the treatment effect,and the patient's renal function status still needs to be considered.The MIC value is helpful in evaluating the effectiveness of vancomycin and teicoplanin in advance and make a decision on the necessity of combined treatment with other antimicrobials.

  • 用药指南
    XU Shanshan,SONG Zhihui,ZHANG Chao
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    Objective To investigate and analyze the situation and evidence-based medicine of off-label uses for chemotherapy adjuvant medications in children with a solid tumor,to provide references for rational clinical use for chemotherapy adjuvant medications in children. Methods Medical orders of chemotherapy adjuvant medications in children with the solid tumor in the fourth quarter of 2019 in the department of pharmacy of Beijing Tongren Hospital of Capital Medical University were retrospectively investigated. The medical orders of off-label medication were analyzed by reference to the latest dispensatory approved by the China Food and Drug Administration and were analyzed according to the evidence-based medicine. Results A total of 564 children with the solid tumor in the department of pediatrics in Beijing Tongren Hospital were collected,including 9978 medical orders,of which 4821 were orders of chemotherapy adjuvant medications with 23 medications. There were 18 off-label medications with 4032 orders,accounting for 40.41% of all the orders and 83.63% of all the orders of chemotherapy adjuvant medications. In the 4032 medical orders,1863 (46.21%) were over-indications,1209 (29.99%) were inappropriate patients,798 (19.79%) were overdose medications and 162 (4.02%) were over-frequency medications. There were no under contra indications and improper administration route medication. In the 18 off-label medications with 19 off-label situations,8 were with Class Ⅱa of effectiveness level,7 with ClassⅡb and 4 with Ⅲ,5 were with ClassⅡa of recommended level,9 with ClassⅡb and 4 with Ⅲ,5 were with Class B of evidence level,10 with Class C, and 4 with no category. Conclusion The incidence of off-label medication for chemotherapy adjuvant medications in children with solid tumors is relatively high; and the evidence level of many off-label medications is relatively low. The administration on off-label medication for chemotherapy adjuvant medications in children needs to be strengthened,and unreasonable off-label medication should be severely restricted to ensure the safety of children's medication.

  • 临床药师交流园地
  • 临床药师交流园地
    DING Yinglong,QIN Qiong,XUE Ling,ZHOU Ling,XIE Cheng,SHEN Zhenya,MIAO Liyan
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    Objective To establish and evaluate the standardized medication monitoring model of warfarin. Methods The patients who needed to use warfarin were selected,and the standardized medication monitoring model of warfarin was established with the PK/PD principle and basic components of pharmaceutical care.Sixty-two patients were randomly divided into standard medication monitoring mode (standard group) and traditional medication monitoring mode (control group).The questionnaires were designed to accessment compliance and awareness with warfarin.And patients will be asked to fill in the questionnaire regularly.The INR reaching time and the incidence of adverse reactions in patients within follow-up were analyzed. Results Standardized medication monitoring model for warfarin was established,including the work system,clinical pathway and comprehensive management,which were embedded in the clinical pharmacist workstation.Compared with the control group,the compliance with warfarin was significantly improved (P<0.05) and the awareness of warfarin was significantly increased in the standard group (P<0.05).The duration of INR reaching the target was significantly shortened (P<0.05).During the follow-up period,the incidence of adverse reactions was reduced by 6.45% in the standard group. Conclusion The established standard medication monitoring model can improve warfarin anticoagulant therapy's safety, effectiveness, and medication compliance.

  • 临床药师交流园地
    LI Yang,MI Jie,XIONG Fengmei,GUO Huanli,CHENG Hua,WU Dongmei
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    Objective To explore the rational intervention of the use of antibiotics in the perioperative period of pediatric neurosurgery type I incision operation by clinical medication pathway to provide a reference for the rational use of antibiotics in pediatric neurosurgery. Methods The clinical medication pathway of prophylactic use of antibiotics in type I incision surgery of neurosurgery has been established. A total of 1484 cases of pediatric neurosurgery from January 2016 to December 2019 with type I incision surgery were enrolled, and the perioperative antimicrobial selection, administration time, usage and dosage, and course of treatment were retrospectively analyzed according to the years. Results From 2016 to 2019, the prophylactic use rate of antibiotics in pediatric neurosurgery decreased from 23.85% before intervention to 20.28%, 17.86% and 17.28%, all lower than 30%. The rational rate of drug varieties increased from 60.26% to 97.26%, 98.57% and 100.00%, respectively. The rational rate of medication timing increased from 93.59% before intervention to 97.26%, 100.00% and 100.00%, respectively. The rational rate of treatment course increased from 26.92% to 76.71%, 82.86% and 84.29%, respectively. Conclusion Implementing a clinical medication pathway can effectively improve the rational rate of prophylactic use of antibiotics in pediatric neurosurgery during perioperative period.

  • 药品不良反应与不良事件
  • 药品不良反应与不良事件
    CAO Yuqing,ZHANG Rui,SHI Yingying,DU Shuzhang
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    Objective To analyze the status and clinical characteristics of adverse drug reactions(ADRs) of anlotinib to provide a reference for clinical rational drug use. Methods PubMed, Web of Science, CNKI, Wanfang database and VIP database were searched for ADRs of anlotinib, and the collected literatures were further analyzed statistically. Results A total of 21 articles were included, involving 25 patients. The average age of the patients was (59.56±11.67) years old. Among them, 14 cases (56.00%) were male and 11 cases (44.00%) were female. The ADR mainly occurred within two months (73.68%) after therapy. ADRs of anlotinib were mainly cardiovascular system injury (28.95%),and followed by respiratory (15.79%), skin and accessory (13.16%) system injury. Conclusion Clinicians and pharmacists should understand the characteristics of the ADRs of anlotinib. More attention should be paid to ADRs of anlotinib to ensure the safety of drug use.

  • 药事管理
  • 药事管理
    DU Wenwen,XU Wei,JING Tianyu
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    Objective To improve the formation mechanism of drug alternative database for the National Essential Medicine List(NEML) and to devise a suitable scheme for the drug alternative database for our country. Methods The scheme was designed based on the experience of other countries and areas,combined with the practicability of NEML adjustment,the orientation of NEML,and the connection with medical insurance policies from the theoretical and practical aspects.After that,taking advantage of the available information and the purchasing data of medical institutions in 2020, these data were used to simulate the formation mechanism. Results The simulation results showed that the drug alternative database of NEML could be transferred from department selection to dominated by the recommended clinical diagnosis and treatment guidelines, and supplemented by medical insurance and medical institutions. Conclusion The new formation mechanism of the drug alternative database of NEML embodies the concept of evidence-based in decision-making and respects the clinical opinions.Beside this,it could set up an effective connection with health insurance policy.It could enhance the usability,authority and scientific entity of NMEL.

  • 药事管理
    CAI Heping,TANG Qi,ZHANG Shengnan,WANG Xiaoling
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    Objective To investigate and analyze the children's medication information in common oral antiallergic drugs's manual in children's hospitals. Methods Collecting thirty-five kinds of drug instructions of common oral antiallergic drugs in eight children's hospitals, medication information labeling on children was investigated and analyzed. Results Among the 35 oral antiallergic drugs,there were five for children only and the other were not for children only. In all 35 drugs, tablets accounted for 51.4%,capsules accounted for 2.9%,and chewable tablets,syrups,granules,drops,oral solutions which were suitable for children accounted for about 45%. In the drug instructions,24 medicines (68.6%) labeled with children's usage and dosage,22 medicines (62.9%) labeled with the items of children's drug use,14 medicines (40.0%) labeled with information of children's pharmacokinetic parameters,and 10 medicines (28.6%) labeled with children's medication information clearly. Compared with the imported oral antiallergic drugs,the absence of children's medication information in domestic oral antiallergic drugs was serious. Among the 22 medicines with the items of children's drug use,there was little information of significant guidance in 16 kinds. Conclusion The oral antiallergic drug instructions show inadequate medication information on children,little guiding significance,and few varieties of medicines for children only,which should be attached to great importance by relevant departments.

  • 药事管理
    ZHOU Ying,LI Yanhui,BAI Xiangjun,LIU Shunfang
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    Since the end of February 2022,the epidemic of Corona virus disease 2019(COVID-2019) in Shanghai has shown a trend of multiple and frequent occurrence,the temporary lack of medical resources in static management.Chronic disease treatment services for infected populations were absent relatively. Shelter hospitals have met the medical needs of patients with chronic diseases,monitor changes of patients with chronic diseases,prevent acute exacerbation of chronic disease or critical disease. Practical experiences have explored the key points of chronic disease management of patients with hypertension and diabetes in shelter hospitals during the COVID-19 epidemic,and have provided the recommend ations of shelter hospitals in response to public health emergencies in China.